EXCIPIENT NORTH. technology forum. A technical event specifically designed for the Canadian Pharmaceutical formulation community.

Transcription

1 EXCIPIENT NORTH technology forum WEDNESDAY OCT 19TH 2016 LAVAL, QC A technical event specifically designed for the Canadian Pharmaceutical formulation community. Presented By

2 RESERVE YOUR SEAT NOW! WHAT IS IT? A technical forum aimed at the Canadian Pharmaceutical Formulation community. Presentations from eight global excipient suppliers on new products, studies and formulation technologies that offer technical insights on today s excipient formulation technologies and processing options. A USB with all presentations and a certificate of participation is provided. There is no cost if you register prior to the event. WHEN IS IT? Wed., October 19, :00 a.m. 5:00 p.m. Event Check in starts at 8:30am WHERE IS IT? Chomedey Room Sheraton Laval Hotel 2440 Autoroute des Laurentides Laval, Quebec, H7T 1X5 Tel: HOW DO I REGISTER? Contact Jamie Elliott of Chemroy with the following: Your Name, Company, Title Telephone number, address jelliott@chemroy.ca SCHEDULE AT A GLANCE AGENDA AT A GLANCE 8:30am Event Check-in Begins 9:00am Welcome to Excipient North :10am 9:50am Rotary Tablet Press Tooling: Standards, Inspection and Troubleshooting - Fazal Mohideen, NATOLI Aquacoat ECD30: Easy Cure System - Yeli Zhang, FMC 10:30 am BREAK - Coffee, Tea, Snacks Provided 10:50am 11:30am 12:10pm 1:30pm 2:10pm 2:50pm 3:10pm 3:50pm 4:30pm Tableting productivity enhancements from high efficiency binder - Wade Tanev, NISSO New Advancements in Film Coating Technologies - Charlie Cunningham, COLORCON LUNCH - Buffet Provided at La Piazza Restaurant, Sheraton Laval Ludipress : A lactose based directly compressible dry binder - Shaukat Ali, BASF Co-processed excipient technologies available for the development and manufacture of solid oral dosage forms - Joseph Zeleznik, MEGGLE BREAK - Coffee, Tea, Snacks Provided Process and formulation factors in continuous twin screw granulation - Kevin O Donnell, DOW Fuji s Problem-solving Excipients - Xi Han, Fuji Chemical Industries USA, Inc. Final Q&A, Closing Remarks & Ticket Giveaway

3 9:10am Rotary Tablet Press Tooling: Standards, Options, Inspection and Troubleshooting - Fazal Mohideen, NATOLI This presentation will cover key parameters in tablet production offering best practices and strategies. An outline of basic tooling standards, configurations and a review of die segments will be provided. We will examine common tablet compression problems like sticking and picking, splitting, capping and lamination while looking a potential solutions to each irregulatirty. Proper maintainence and anaylsis techniques for keeping equipment in peak performance ranges will be offered. Soultions to extend tool life and addressing common issues, like the impact of dust will be discussed, concluding with a Q&A window for your specific questions. Natoli Engineering Company Inc. Overview: Founded in 1973 and considered a leader in manufacturing, Natoli Engineering has over 40 years of experience in delivering tablet compression products and services to pharmaceutical, nutritional, confectionery, industrial and veterinary industries around the globe. Our commitment to innovation and excellence has earned us an International reputation for high quality and reliability. Mr. Mohideen has 19 years in the formulation development business within the pharmaceutical industry, including 3 years as Senior Scientist at Merck Generics; 2 years as Manager of Formulation Development at Teva Canada; and 3 years as Manager, Technical Sales for Natoli Engineering in Canada. Fazal has patents within the US, Canada and EU within his 19 years in the pharma business, and has developed over 400 molecules for Canadian, EU and US markets. He has many years of experience in product development, scale up processing, analytical troubleshooting, dry/wet granulation, roller compaction, tableting, coating, and encapsulation. 9:50am Aquacoat ECD30: Easy Cure System - Yeli Zhang, FMC An Introduction to Aquacoat ECD30 Easy Cure System featuring the latest testing data results from FMC. The presenter will provide: Introduction to innovative studies to achieve stable aqueous ethyl cellulose coating without curing, with the aid of coalescence agent; Understanding of critical formulation and process attributes with the use of coalescence agent, and the mechanism to achieve robust product with consistent dissolution; Application case studies of Aquacoat ECD easy cure system in controlled release. FMC BioPolymer Overview: FMC BioPolymer provides oral dose form drug delivery solutions, assisting our customers in bringing drugs to market faster and making their operations more cost effective. FMC s ability to help with customer formulation challenges is unrivaled due to our well-controlled products, decades of formulation and manufacturing experience and staff dedicated to our customer s success. FMC Corporation is a specialty company serving agricultural, industrial and consumer markets globally for more than a century with innovative solutions, applications and quality products. 10:50am Tableting productivity enhancements from high efficiency binder - Wade Tanev, NISSO A new direct compression binder has been quickly adopted by tablet manufacturers to improve press speed, tooling life, first pass quality, and profitability. Nisso developed Super Fine Powder (SFP) technology to create a novel grade of hydroxypropyl cellulose for direct compression and roller compaction. It combines a micronized particle size with ultra-low molecular weight for unprecedented tablet binder efficiency without impacting dissolution. Case studies for hardness enhancement and capping prevention will be presented along with a business case for profitability improvement. Nisso America Inc. Overview: Wade Tanev is the Technical Sales Director for Nisso America. Nisso America Inc. is the U.S. subsidiary of Nippon Soda Co. Ltd., Tokyo, Japan. Nisso America imports and markets chemicals in the pharmaceutical, agricultural, paper and other industries. Pharmaceutical excipient products include Nisso HPC, a high quality Hydroxypropyl Cellulose, available in a wide range of viscosities in regular, fine powder, and super fine powder types.

4 11:30am New Advancements in Film Coating Technologies - Charlie Cunningham, COLORCON Over the past decades there has been little change in the basic design of manufacturing scale film coating equipment. However, recent industry trends toward more manufacturing flexibility, faster change-overs, variable batch sizes and continuous tablet manufacture have led many coating equipment companies to introduce improved, or completely new, batch, continuous and semi-continuous coating equipment designs. Some of these designs differ considerably from traditional coating process configurations but common themes are rapid coating cycle times, improved throughput flexibility and in some cases smaller manufacturing footprints. Coating formulations also need to provide maximum flexibility for efficient use in these new and emerging coating processes as well as in traditional batch pans. Optimal coating formulations should offer the widest flexibility in solids concentrations, application rates and drying properties while providing exceptional coated tablet quality and appearance. Colorcon has introduced an innovative coating system that is proving to meet these needs. Opadry QX, Quick and Flexible Coating System, was designed to expand the range of process parameters and application speeds that can be used, irrespective of coating equipment design. In this presentation, case studies will be presented demonstrating the flexibility of this new coating system in traditional batch and newly designed semi continuous and continuous, coating processes. Colorcon Overview: Charlie Cunningham is a Senior Manager in the Product Development Group at Colorcon. In his 23 year career at Colorcon, Charlie has focused on coating process applications and the scale-up and optimization of aqueous film-coating processes. Charlie has authored several articles in the areas of immediate release and delayed release film coating technologies as well as solid oral dose formulation and excipient technologies. He holds four patents related to novel film-coating and excipient formulations. Colorcon is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical industry. 1:30pm Ludipress : A lactose based directly compressible dry binder - Shaukat Ali, BASF Interests in direct compression and roller compaction continue to rise in formulation development to avoid wet granulation, reduce time and save cost. The excipients selection is important in improving the tensile strength, and hence improving the friability of solid oral dosage tablets. Co-processed excipients such as the lactose based Ludipress and Ludipress LCE have been used in direct formulations to improve the compressibility, friability, hardness and performance of tablets. Likewise, the mannitol based Ludiflash has been used in formulation of orally disintegrating tablets (ODT). Comprised of lactose, povidone (Kollidon 30) and crospovidone (Kollidon CL) as a co-processed excipient, Ludipress is suited for a wide range of drugs in direct compression. This presentation will focus on the physico-chemical properties and applications of Ludipress and Ludipress LCE in tablet formulations with poorly compressible crystalline model drugs. The relevant attributes and performances of the co-processed excipients and commercially available lactose used as a dry binder will also be discussed. BASF Pharma Solutions Presenter: Dr. Shaukat Ali worked in the Pharma industry for over 22 years including 12 years at BASF where he supports Solubilization and Instant & Modified release platforms. His area of expertise includes controlled release, lipid based emulsifying systems (SEDDS), liposome drug delivery, and film development technology. He holds a PhD in chemistry from the City University of New York, and has published over 37 articles in scientific journals and inventor in 14 US Patents. He is a member of editorial board of several pharmaceutical journals and is also serving as the Editor-in-Chief of Journal of Analytical and Pharmaceutical Research. He also serves in the USP expert committee for General Chapters - Physical Analysis.

5 2:10pm Co-processed excipient technologies available for the development and manufacture of solid oral dosage forms - Joseph Zeleznik, MEGGLE Co-processed excipients provide numerous benefits in pharmaceutical product development and manufacture. Enhanced functional performance through particle engineering creates technical and financial advantages over traditional ingredients in simple mixtures or processed via granulation methods. Reducing challenges by increasing predictability and efficiency make co-processed excipients attractive. The speaker will review co-processed excipient technologies available for the development and manufacture of solid oral dosage forms as well as discuss the latest co-processed excipient innovations. Meggle: Excipient and Technology Overview: Excipient and Technology is a business group within 122 years old Meggle Holding and dedicated to pharmaceutical excipients, exclusively. From its beginnings production covered milled and sieved lactose grades, followed by the development of the first agglomerated (e.g. Tablettose 70/80100) and subsequently spray-dried (FlowLac 90/100) lactose type. For all kind of pharmaceutical granulation processes a broad variety of so called co-processed materials, as Cellactose80, Microcellac 100 or Starlac is available, as well. Since 2000 inhaler grade lactose types can be found in the product portfolio. Meggle is constantly working to develop high-tech, functional products for implementation in customer applications, where they can deliver maximum performance. Even with advances in innovation, Meggle remains what they always have been: a family business with strict values and high standards. Performance and partnership with customers is at the core of Meggle s success. 3:10pm Process and formulation factors in continuous twin screw granulation - Kevin O Donnell, DOW Twin screw granulation enables the continuous granulation of pharmaceutical formulations to improve powder flow, compressibility, and content uniformity. The introduction of the binder as a foam rather than a liquid offers unique advantages in this technology such as a reduction in the required binder content and lower product temperatures. This talk will focus on the process and formulation factors in continuous twin screw granulation utilizing a foamed aqueous binder critical for proper particle formation and designing a robust process. Dow Pharma and Food Solutions Overview: Kevin O Donnell, Ph.D. is an Associate Ressearch Scientist with Dow Pharma & Food Solutions. Dow designs differentiated solutions that enable pharmaceutical delivery & nutritional benefits to customers around the world. A business of Dow Consumer Care portfolio, Dow Pharma & Food Solutions offers a single interface to all Dow technologies and expertise focused on solutions serving the pharmaceutical and food manufacturing markets. Dow provides functional excipients, active pharmaceutical ingredients (APIs) and highly functional food ingredients to help consumers live healthier, more convenient and enjoyable lives. 3:50pm Fuji s Problem-solving Excipients - Xi Han, Fuji Chemical Industries USA, Inc. In this presentation, three of these high performance excipients, Fujicalin, Neusilin and F-MELT will be introduced and case studies will be discussed in detail. Neusilin: the mesoporous carrier that has made solid dispersion a viable technology and a competent adsorbent for liquid and SMEDDS. Fujicalin: the perfect sphere for direct compression and granulation for oily/sticky active ingredients, which improves blend uniformity, promotes rapid disintegration and superior vehicle for drug layering. F-MELT: the directly compressible ready-to-use excipient for ODTs. F-MELT provides good mouth feel and good tablet stability. Fuji Chemical Industries USA, Inc: Fuji s primary mission is to provide high quality and unique specialty excipients. Fuji is a wholly owned subsidiary of Fuji Chemical Industries Co., Ltd. of Toyama, Japan. Fuji Chemical, founded in 1946, is a manufacturer of pharmaceutical ingredients. Over the years, Fuji Chemical developed a unique and proprietary technology for powdering which led to the development of excipients with extraordinary properties. Through this technology, Fuji Chemical can offer specialty, high performance excipients worldwide. These excipients have helped our customers overcome challenges in different aspects during the product development and formulation stages.